Press Release
Crossject reports
financial results and business highlights
for first half of 2023
Strong progress in bringing drugs for use in
emergency situations towards the market
Further strengthening of financial structure to
accelerate company's development
Concluded licensing agreement for ZENEO®
Midazolam for Australia and New Zealand
Progress in the operating income, net result, and
cash flows
Dijon, France September
26, 2023, 17:35
CET -- Crossject
(ISIN: FR0011716265; Euronext: ALCJ), a
specialty pharma company developing needle-free
auto-injectors for emergency
situations, announces its financial results for the first
six months of 2023, ending June 30.
"Crossject has made substantial progress so far
in 2023 as we move our portfolio of drugs for use in rescue
therapies further towards the market," said Patrick
Alexandre, President of the Executive
Board of
Crossject. "Since the beginning
of the year, we strengthened further our financial position by
cashing in €8 million from the €14 million non-dilutive financing.
We also concluded a new licensing agreement for our innovative
rescue treatment of epileptic seizures, ZENEO® Midazolam, for
distribution in Australia and New Zealand. Our manufacturing sites
have also passed European and U.S. audits, enabling us to expand
capacity as we advance our vision to be a world leader in
developing rescue therapies that can be safely used by patients,
caregivers and untrained first responders. In particular, the
successful outcome of the preparatory U.S. audit confirms our
manufacturing readiness as we advance towards regulatory clearance
for our strategic ZENEO® Midazolam contract with the Biomedical
Advanced Research and Development Authority (BARDA). These
accomplishments, coupled with Crossject’s robust cash balance,
expansion of our BARDA collaboration, and further strengthening of
our Supervisory Board, position us well to deliver on our long-term
strategic objectives."
Notable milestones
Non-dilutive financing
Crossject cashed in early 2023 €8 million, in
addition to €4 million at the end of 2022, from a combined
non-dilutive financial transaction of €14 million to accelerate the
company's development. The transaction includes various loans
granted by its long-standing banks (Caisse d'Epargne and BNP),
Société Générale and BPI, with amortization periods ranging from 5
to 10 years.
Appointment of Daniel Teper
as a member of
the Supervisory Board
With a PhD in Pharmacy from Paris-Saclay
University and an MBA from INSEAD, Daniel Teper is a U.S.-based
pharmaceutical industry leader and entrepreneur with a compelling
background spanning the fields of marketing, capital markets,
strategy and development.
hErOiSme² project
The French Ministry of Armed Forces (Ministère
des Armées) selected the project offered by a research consortium
to develop a new molecule for rescue therapies for hemorrhagic
shock treatment with ZENEO® auto-injector. Many civilian and
military lives could be saved by promptly stabilizing the condition
of a person suffering from hemorrhagic shocks. Crossject and IDD,
its long-term regulatory partner, have officially joined this
3-year-long research program with a total budget of €800,000.
Events beyond the reporting period
New licensing agreement on ZENEO®
Midazolam epilepsy rescue therapy
Crossject signed an Australia & New Zealand
commercial agreement with AFT Pharmaceuticals for ZENEO® Midazolam,
its innovative rescue therapy for epileptic seizures. AFT
Pharmaceuticals is a particularly well-suited partner because of
its strong regional presence and extensive experience with
successful commercial launches.
Successful completion of
European and U.S. audits
Crossject's manufacturing sites in Dijon and
Gray (France) passed an annual ISO certification audit, expanded
their scope of certification by the French Health Agency, and
received positive feedback after an audit by the Biomedical
Advanced Research and Development Authority (BARDA), part of the
Administration for Strategic Preparedness and Response within the
U.S. Department of Health and Human Services, on compliance of
manufacturing ZENEO® Midazolam for the U.S. market.
In 2022, Crossject was awarded a $60 million
contract with the U.S. Biomedical Advanced Research and Development
Authority (BARDA) to procure ZEPIZURE® for nerve agent-induced
epileptic seizures upon receiving FDA authorization. BARDA is
also funding the US advanced regulatory development until FDA
Emergency Use Authorization and New Drug Approval and has options
for further procurement for a total contract value of $155 million
if all options are exercised.
Significant improvement in
Gaïa ESG rating
Crossject’s new score of 73/100 is significantly
up from 60 last year and 46 in 2021. Crossject's Gaïa rating,
compiled by EthiFinance ESG Ratings, increased across all four
themes: governance, social, environment and external stakeholders.
There were particularly notable improvements in the ratings for
environment and external stakeholders' performance.
Financial information as of
June 30,
2023
In € thousands |
H1 2023 |
H1 2022 |
Operating income |
7,926 |
3,374 |
Operating expenses |
14,461 |
10,333 |
Purchases of raw materials and supplies |
0,576 |
0,248 |
Other purchases and external expenses |
4,456 |
3,566 |
Personnel expenses |
4,098 |
3,628 |
Taxes and duties |
0,120 |
0,075 |
Depreciation, amortization and
provisions |
4,952 |
2,698 |
Other expenses |
0,258 |
0 |
Operating profit/(loss) |
(6,535) |
(6,959) |
Financial income/(expense) |
(263) |
0,044 |
Exceptional income/(expense) |
585 |
(109) |
Corporate tax |
1,651 |
1,150 |
Net profit/(loss) |
(4,562) |
(5,874) |
Financial statements for the six months to 30 June 2023 were
sanctioned by the Management Board and examined by the Supervisory
Board at its 25th September 2023 meeting.
The strengthening of Crossject’s financial
structure and strict cash management resulted in a cash position of
€5,391,000 as of June 30, 2023.
Crossject working capital increase amounts to
€2,255,000. This includes an increase in inventory by €375,000, a
decrease in payables to suppliers by €121,000, an increase in
customer receivables by €363,000, and tax-related receivables
amounting to €1,423,000, of which €1,200,000 can essentially be
considered as cash, being a delayed VAT reimbursement.The increase
in inventory signals a boost in our manufacturing and supply chain
activities. Additionally, the 'customer' category refers to an
increase in our invoicing as per the contract with BARDA.
About Crossject
Crossject
SA (Euronext: ALCJ; www.crossject.com)
is an emerging specialty pharma company. It is in advanced
regulatory development for ZEPIZURE®, an epileptic rescue therapy,
for which it was awarded a $60 million contract with the U.S.
Biomedical Advanced Research and Development Authority (BARDA).
ZEPIZURE® is based on the Company’s award-winning needle-free
auto-injector ZENEO®, designed to enable patients and untrained
caregivers to easily and instantly deliver emergency medication via
intramuscular injection on bare skin or even through clothing. The
Company’s other products in development include rescue therapies
for allergic shocks, adrenal insufficiencies, opioid overdose and
asthma attacks.
For further information, please contact:
Investors Natasha DrapeauCohesion Bureau+41 76 823
75 27natasha.drapeau@cohesionbureau.com |
MediaSophie BaumontCohesion Bureau+33 6 27 74 74
49sophie.baumont@cohesionbureau.com |
|
- 2023-09-26_Crossject Press Release_H1 2023_EN
Crossject (EU:ALCJ)
Historical Stock Chart
From Apr 2024 to May 2024
Crossject (EU:ALCJ)
Historical Stock Chart
From May 2023 to May 2024